Events

Recall of Quidel Sofia Legionella FIA. An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Thermo Fisher Scientific Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-01034-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01034-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Investigations have confirmed that certain lots of quidel sofia legionella fia may give a false positive reading in some cases some cases due to rheumatoid-like factors present in the urine of some patient specimens. revised instructions for use (ifu) are being provided which specifically references instances where these rheumatoid-like factors may be present and recommends a method for testing these particular patient samples.
  • Action
    Thermo Fisher is providing users with a revised IFU which includes instructions on the treatment of samples when a false positive is suspected.

Device

Quidel Sofia Legionella FIA. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Quidel Sofia Legionella FIA. An in vitro diagnostic medical device (IVD) Catalogue Number: QUI20244Lot Numbers: 100812,103284,104721,109609,110854,111447,217581,701553ARTG Number: 250592
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd